Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
A Proof-of-Concept Study of a Novel Method for Removal of Residual Oropharyngeal Inhaled Corticosteroid Deposits in Asthma
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will be on study for up to 3 weeks."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether olive oil mixed with water removes more fluticasone propionate, an inhaled steroid medicine, from the mouth than water alone. It will test two mixes: half oil and half water, and three parts oil to one part water. The study is for healthy adults and adults with asthma and lasts up to 3 weeks.
This study is to find out if an Extra Virgin Olive-Oil-based Water (EVOOW) mix, removes more Fluticasone Propionate (FP) from the mouth than Water alone. 2 strengths of the EVOOW mix will be tested, one with equal parts EVOO and Water (50/50) and one with 3 parts EVOO and 1 part Water (75/25). Removing more FP deposits may help decrease the risk for obstructive sleep apnea (OSA), candidiasis (thrush), and speech and swallow dysfunction. Participants will be on study for up to 3 weeks.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older, either healthy or with asthma.
- Willing to stop steroid medicines inhaled through the mouth for 24 hours before visits 2 and 3, when mouthwash samples are collected.
- Willing to stop steroid medicines inhaled through the nose for 12 hours before visits 2 and 3.
- No use of steroids that act throughout the body or steroids applied to the eyes in the past 4 weeks.
Who can't join
- Known allergy or sensitivity to fluticasone propionate.
- Allergy to olives or olive oil.
- Known allergy to oxymetazoline.
- Currently smoking or vaping.
- Pregnant or trying to become pregnant.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Healthy adults and adults with asthma, age 18 years and older * Willing to hold orally and nasally inhaled corticosteroids (ICS) for 24h and 12h, respectively, before study visits with mouthwash sample collections (Visit 2 and Visit 3) * No systemic or topical ocular corticosteroid use for the prior 4 weeks. Exclusion Criteria: * Known hypersensitivity to fluticasone propionate * Allergy to olives or olive oil * Known allergy to oxymetazoline * Current smoking or vaping * Currently pregnant or trying to become pregnant.
Study sites (1)
WI
- University of Wisconsin · Madison, WI 53792More trials in Madison